Pathogen barrier with optically transparent end

ABSTRACT

A disposable pathogen barrier of a material which is highly elastic and stretchable, yet tear-resistant, and capable of being placed in proximate contact and covering an entirety of a variety of elongated, tubular-shaped intra-oral medical or dental tools or implements which emit lightwaves in pre-determined ranges without distorting, interrupting or shifting the wavelength of the emitted light, or the receiving of reflected light, by the use of, in a first embodiment, an optically transmissive end and, in a second embodiment, an optically clear film to provide the required range of transmissivity of light.

BACKGROUND OF THE INVENTION

Dental practitioners have been aware for years that the repeatedhandling of a dental tool by gloved or ungloved hands after either thedental practitioner's or the hygienist's hands have been in or aroundthe mouths of several different patients without proper sterilizationcan bring about the spread of contagious diseases. Such contagious orcommunicable diseases are borne in or on the body fluids and/or tissueswhich may become attached to the tool or to the exterior surfaces of thegloved or ungloved hands of the dental practitioner or hygienist andthen transmitted to the dental tool or implement, such as an intra-oralcamera or an ultraviolet curing light, through contact. More recently,the spread of the hepatitis virus and the acquired immune deficiencyvirus have caused great concern among dental practitioners, dentalhygienists and other staff members not only for their patients, but alsofor their own health and well-being.

The hepatitis virus and the acquired immune deficiency virus have beenfound to be carried in or on body fluids and/or tissues. In theenvironment in which dental practitioners, hygienists and dental staffmembers work, i.e. inside the mouth, bodily fluids such as saliva,blood, tissues comprising the gum and portions of the teeth, the pulpand root, etc. may potentially transmit the virus form through contact.The process of cleaning and/or repairing teeth by filling caries,performing a root canal procedure or performing restorative or cosmeticdentistry requires the drilling of the teeth and the subsequentscattering of tissue particles and body fluids about the mouth.

During restorative and cosmetic dental procedures, an intra-oral cameramay be inserted into the mouth in order to view particular areas withinthe mouth which are difficult to view, or which can be seen more clearlythrough the enlargement provided by the monitor attached to the camera.It is also possible that during restorative and cosmetic dentalprocedures an ultraviolet curing light may be inserted into the mouth ofthe patient in order to effect the polymerization of the materialsutilized in the restorations of the teeth. Some of the particles and/orfluids which potentially carry disease causing organisms may becomeattached or adhered to the gloved or ungloved hand of the dentalpractitioner, hygienist or other dental staff member, or to theunsheathed exterior of the intra-oral camera or the curing light. Whileit is possible to remove and discard the protective gloves, cleaning andsterilizing the exterior of sensitive electronic or narrow bandillumination devices such as the intra-oral camera and ultravioletcuring light, between use on patients has become a serious problembecause of their specialized construction.

During dental procedures ranging from cutting and shaping teeth forreceiving caps and/or more extensive bridge work and restoration, or thenewer cosmetic dentistry using certain polymers to build up or repairthe teeth, the ultraviolet curing light may be placed into the interiorof a patient's mouth in close proximity to the tooth or teeth beingrepaired to effect the curing (or polymerization) of the polymermaterials used to restore the tooth or teeth through the use of certainvisible lightwaves, i.e. infrared range illumination. The light guideportion of the curing light is placed into the patient's mouth by thedental practitioner or other staff member in order to effect the desiredcuring of the restoration and repair material.

The problem of disease transmission occurs as the curing light isreplaced in its holder for subsequent use, possibly on a differentpatient, without attention to cleaning and sterilization. Anything thelight guide may have come into contact with while in the patient's mouthmay have become attached to the light guide and be transmitted to thenext patient on whom the curing light is used. The mere swabbing down ofthe light guide with a disinfecting solution will not sterilize thecuring light, nor will it kill all of the bacteria and virus forms whichmay have become attached thereto.

The same is true for an intra-oral camera, containing a dentalillumination lamp, which is used by the dental practitioner toilluminate and view, on the associated enlarged video monitor,particular areas of the patient's mouth. Because of the long, narrowtubular construction of the intra-oral camera, and its use eitherduring, intermediate, or subsequent to certain procedures within thepatient's mouth, whatever may have been dislodged in the form of tissueor other tooth material or in the form of bodily fluids may becomeadhered to the exterior of the intra-oral camera and be transmitted tothe next patient on whom the camera may be used. As in the earlier case,the swabbing down of the exterior of the camera body with a disinfectingsolution will not sterilize it nor will such swabbing kill all of thebacteria and virus forms which may have become attached thereto. Thesame will be true for a dental illuminating lamp having similarconstruction (but without the video capabilities) used for illuminatingthe work place within the patient's mouth.

There have been some attempts to provide sterile sheaths for otherdental tools, i.e. the dental handpiece or drill. U.S. Pat. No.4,266,935 Hoppe! and U.S. Pat. No. 4,728,290 Eisner, et al.! provideapparatus which are particularly adapted for use with the dental handpieces in use today. Neither of these devices address the problem ofsheathing either the dental curing light or the intra-oral camera with asterile shield or barrier which prevents pathogenic contamination butpermits the visible lightwaves to be emitted without interruption orwavelength shifting.

There have also been attempts to provide sheaths to other dental orsurgical implements, which sheaths provide protection against carryingbacteria and/or virus forms onto the exterior surfaces of the particularimplements or tools. U.S. Pat. No. 3,794,091 Ersek, et al.! discloses asterile sheath for enclosing an elongated surgical illuminating lamp(endoscope) with a light transmitting lens means disposed at the tip ofthe light transmitting shaft of the lamp structure. The sheath of Ersekis required to be made of a thermoplastic, thermosetting film in orderto provide the necessary durability, rigidity and transparency requiredof the device. Because the sheath may be inserted through fairly longbody canals, the sheath is required to exhibit the describedcharacteristics in order to go around or through obstructions, besufficiently flexible to bend around turns, curves or corners, yet stillretain sterile integrity so that the sheath or barrier is not breached.

Another attempt is that made by U.S. Pat. No. 4,757,381 Cooper, et al.!which describes a sheath for placement over and around a dental camera.However, the Cooper device does not snugly overlie the dental camera andrequires attachment by rotationally twisting the sheath and securing itat either end of the dental camera so that the twisted and rotatedsheath remains in that position to achieve the prevention ofcross-contamination from patient to patient from subsequent uses of thedental camera. The disclosure particularly describes a transparent,clear plastic material which is used to cover the dental camera, butwhich material does not exhibit any significant elasticity or strengthbeyond that necessary to resist minimal tearing when the rotating andtwisting motion is utilized to secure the sheath in position.

An attempt to provide a transparent cover to a light ray radiationdevice was made in U.S. Pat. No. 4,804,240 Mori!. The descriptionindicates that the cover member which covers the light radiator having ahat-shaped elastic body which is capable of transmitting the visiblelight ray components transmitted into the optical conductor cable. Thecover member, although made to be disposable, may be cleaned anddisinfected for repeated use. Since the disclosure describes the covermember being made from a transparent and resilient material, and thatthe cover member as a swordguard-shaped portion (as shown in FIG. 2a)which guard retains its shape, the cover member must be non-elastic.

With all of these earlier patents, there lacks an enabling disclosurewhich describes for an elastic sheath or barrier which can besuperextended over the exterior surface of a dental tool or implementused in dental or medical procedures which can simultaneously providethe transmissivity for pre-determined light wavelengths whilemaintaining the cross-contamination barrier for the named pathogens.

The dental curing light and/or the intra-oral camera and illuminatinglamp (as well as other medical devices) are not usually thought of asdisease transmission devices. They are customarily cleaned with adisinfecting agent, but not sterilized in the normal course. Some of thelight guide elements of curing lights or dental cameras and illuminatinglamps are detachable for sterilization in an autoclave. However,detachment and reattachment for purposes of sterilization is notbelieved to occur with the frequency required (between each patient) asis done for other dental tools and instruments which may be sterilizedin an autoclave. Hence, sterilizing most likely does not occur betweenpatients and current practice would lead one to believe that only adisinfectant swabbing of the curing light or camera or illuminating lampmay be done between contact with patients to preventcross-contamination.

In recent years, dental practitioners, hygienists and others in both thedental and medical professions have become increasing aware of the rapidspread of communicable diseases borne on body fluids and tissues such asmay be dislodged and become attached to dental implements or the glovedor ungloved hands of dental or medical practitioners, hygienists, nursesor other staff members during procedures being performed within the bodyof a patient. In fact, dental and medical practitioners, along withtheir respective staff members, have been cautioned to protectthemselves from infection by using sterile gloves and masks, and to useprotective glasses, when practicing dentistry or other dental procedureson their patients. Recently, the rapid spread of the hepatitis virus andthe acquired immune deficiency virus has caused significant concernamong these practitioners. The American Dental Association and AmericanMedical Association, as well as other professional organizations, havestrongly urged that health care practitioners and their staff memberstake additional steps to decrease the chance of spreading disease bycross-contamination through the use of non-sterile implements.

It is, therefore, an object of the present invention to provide aprotective pathogen barrier for tools or implements which may beinserted into the mouth or body of a patient which emit light in apre-determined wavelength to significantly reduce or prevent the spreador cross-contamination of contagious, communicable diseases.

It is a further object of the present invention to provide such abarrier which is disposable after a single use and which is easilyapplied and removed so that it would have wide-spread acceptance in thedental and medical professions.

It is another object of the present invention to provide such a barrierwhich is highly elastic and stretchable, yet tear resistant, and whichis capable of covering the entirety of a variety of elongated,tubular-shaped dental tools or implements which emit lightwaves inpre-determined ranges without interrupting or affecting the emission ofsuch light, or the receiving of reflected light, by use of a lens meansto provide the required transmissivity of light during dental or medicalprocedures.

Other objects will appear hereinafter.

SUMMARY OF THE INVENTION

The present invention may be described as a disposable pathogen barrierfor placement over and in proximate contact with a light emitting meansfor significantly reducing the spread of communicable and infectiousdiseases which may be transmitted by or through contact with human bodyfluids and tissues during a first and subsequent use of said lightemitting means in conjunction with the treatment of two or more patientseliminating the need for repeated sterilization of said light emittingmeans between such uses for two or more patients. The disposablepathogen barrier is comprised of an elongated tubular sleeve terminatingin a substantially circular aperture at a first end thereof ofsufficient size for fitting over said light emitting means andpreventing contamination of the outer surfaces of said light emittingmeans. The barrier also has sufficient elastic material memory tomaintain itself in position covering said light emitting means withoutslippage until manual removal.

The barrier, in a first embodiment, has an optically transmissive secondend which overlies in juxtaposition and covers the illumination means ofsaid light emitting means. The optically transmissive second end of saidbarrier freely passes light rays from said light emitting means withoutdistortion, interruption or light wavelength shifting.

Although the optically transmissive second end of said barrier in thefirst embodiment may be made from the same material as the sleeve, theoptically transmissive second end, in a second embodiment, may befurther comprised of an optically clear film inserted into asubstantially circular die cut in said sleeve proximal said second endand positioned along the interior surface of said barrier by an adhesivebond around the periphery of said die cut. The adhesive positions theclear film and provides a seal for preventing contamination of thesurface of the light emitting means. The optically clear film having athickness in the range between 0.025 and 0.080 inches.

The barrier may be made from an elastomeric or elastic material, naturalor man-made, or combinations thereof. The barrier also exhibitssufficient deformability, toughness and tear-resistance to stretch oversaid light emitting means and to withstand pulling and stretching duringapplication and removal. The light emitting means may be any one of thegroup consisting of intra-oral cameras and dental material curing lamps.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the invention, there is shown in thedrawings forms which are presently preferred; it being understood,however, that the invention is not limited to the precise arrangementsand instrumentalities shown.

FIG. 1 is a side elevational exploded view of the pathogenic barrier ofthe present invention partially extended and prepared for applicationover an intra-oral dental camera.

FIG. 2 is a side elevational view of the pathogenic barrier of thepresent invention as applied over the exterior of an intra-oral dentalcamera.

FIG. 3 is a side elevational exploded view of the pathogenic barrier ofthe present invention partially extended and prepared for applicationover an infrared curing lamp and lightwave guide.

FIG. 4 is a side elevational view of the pathogenic barrier of thepresent invention as applied over the exterior of an infrared curinglamp and lightwave guide.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description is of the best presently contemplatedmode of carrying out the invention. The description is not intended in alimiting sense, and is made solely for the purpose of illustrating thegeneral principles of the invention. The various features and advantagesof the present invention may be more readily understood with referenceto the following detailed description taken in conjunction with theaccompanying drawings.

Referring now to the drawings in detail, where like numerals refer tolike parts or elements, there is shown in FIG. 1 a pathogen barrier orshield 10 having a closed end 12 and has an elongated, tubular body 14.The barrier or shield 10 may be formed from any elastomeric or elasticmaterial, natural or man-made, or any combination thereof. Theelastomeric or elastic material should exhibit sufficient deformabilityto stretch over a variety of differently shaped and sized dental ormedical illumination devices as will be described with moreparticularity below.

The elongated, tubular body or sleeve 14 is formed as a tube with bothends open. The end into which any of the dental or medical devices willbe inserted, the proximal end 16, has a beaded lip 18. The other end ofthe tube will have a round, die-cut hole or aperture into which anoptically clear plastic film 20 is positioned. The optically clearplastic film or window 20 (which may be either elastic or non-elastic)has one side coated with an optically clear or translucent adhesive andis adhered within the die-cut end 12 to the sleeve 14. The window 20 ispreferred to have a thickness of approximately 0.003 inches, but athickness in the range of 0.025 inches to 0.080 inches has been found tobe acceptable.

The barrier or shield 10 can be provided with the window 20 in positionover the die-cut end 12 if usage is to be for sterile individuallypackaged barriers for medical or dental use. If the barrier or shield 10is required to provide only an anti-contamination surface, the window 20can be provided as a separate component on a continuous dispenser rollto be positioned and adhered in place by the user. Since the barrier orshield 10 is to be placed in position over the medical or dentalimplement by unrolling the elasticized barrier over the exterior surfaceof the implement, the user is able to firmly adhere the window 20 ontothe internal surface of the sleeve 14 around the die-cut end 12 to forman adhesive bond between the sleeve 14 and the window 20 at the die-cutend 12, which bond provides a seal sufficient to prevent thecontamination of the medical or dental implement to be shielded duringuse. Then the barrier or shield 10 can be applied to the medical ordental implement as described.

With reference to FIGS. 1 and 2, an intra-oral dental camera 22 is shownhaving light guide sheath 24 entering the body at a first end of thecamera 22. At the opposite end of the camera 22 there are mounted a pairof illuminating lamps 26a, b bracketing the fiber optic receptor 28 forcapturing the reflected light images and transmitting that light fordisplay on a video monitor. Both the "white" light for purposes ofillumination through lamps 26a, b and the reflected image captured bythe receptor 28 are transmitted through the light guide sheath 24 toequipment for controlling the illumination and for displaying the image.This equipment is not deemed to be part of this invention, and neitherare the hand controls mounted to the dental camera 22, and, therefore,they are omitted from this description.

The sheath or barrier 10 is applied to the dental camera 22 bystretching it over the end of the camera which carries the lamps 26a, band the receptor 28 and then unrolling and stretching the sheath 10 overthe remainder of the exterior surface of the camera 22. The sheath orbarrier 10 is shown fully mounted to the dental camera 22 in FIG. 2. Thewindow 20, when the barrier or shield 10 is unrolled and stretched intoposition on the dental camera 22, extends over and covers the portion ofthe dental camera 22 which carries the illuminating lamps 26a, b and thereflected light image receptor 28.

With specific reference to FIG. 2, the dental camera 22, including theilluminating lamps 26a, b and the reflected light image receptor 28,require the free passage of the visible light rays necessary toilluminate the desired area of the mouth and to receive the reflectedlight from the designated area without distortion, interruption or lightwavelength shifting. This is accomplished by positioning the window 20in approximate juxtaposition covering the illuminating lamps 26a, b andthe reflected light image receptor 28 of the dental camera 22 such thatthe window 20 does not impair any transmissivity of the illuminatinglight or the detection of reflected light from the designated surfaceareas in the mouth of the patient. Hence, the window 20 must exhibit thecharacteristic of optical transparency for the purposes of illuminatingand receiving the reflected light from the designated area. In order toassist in maintaining optical transparency of the window 20, thematerial utilized to form the window must exhibit sufficient flexibilitysuch that it will conform to the shape of the end of the dental camera22 when extending over that end during application and during use.

In showing a different configuration of a light guide means over whichthe barrier or sheath 10 may be applied, reference may be had to FIGS. 3and 4 for use in describing the application of the barrier 10 to adental curing light. The barrier or shield 10 is shown in a partiallyunrolled position separated from the curved light guide means 32 of thedental curing light 30. Mounting and positioning of the barrier orshield 10 is accomplished in a similar manner as was done with thedental camera. The barrier or shield 10 is stretched over theilluminating end of the light guide means 32 and then unrolled andstretched back along and over the light guide means 32. Since only thelight guide means 32 is intended to be inserted into the mouth of apatient, the body, switch means and light fiber sheathing are notcovered. Since only one model of a dental ultraviolet curing lamp isbeing shown in FIGS. 3 and 4, it should not be assumed that the use ofthe barrier or sheath 10 is limited to this particular form. The barrieror sheath 10 of the present invention is usable on other dental curinglamps for covering the light guide means extending into the patient'smouth as all of these light guide means have similar elongated tubularshapes which are either straight or slightly bent as the light guidemeans 32 shown in FIGS. 3 and 4.

With specific reference to FIG. 4, the infrared light rays 34 are shownemanating from the end of the light guide means 32. These infrared raysare transmitted through the barrier or shield 10 without interruption,distortion or wavelength shifting of the emitted light. This isaccomplished by one of two means. The barrier or shield 10 may includethe window 20 in the die-cut end 12 of the barrier 10. A second form ofthe barrier or shield 10 of the present invention eliminates thenecessity for including the window 20 and merely provides a closed end12' for the barrier or shield 10. This closed end 12' permits thetransmission of the infrared light wavelength without distortion,interruption or wavelength shifting, and without the need of creating adie-cut in the end of the barrier or sheath 10 to accommodate the window20, which die-cut enhances the possibility of a barrier breach throughloss of adhesion at the junction between the die-cut end 12 hole and theperiphery of the window 20.

In this manner, the pathogen barrier or shield 10 of the presentinvention presents an optically transparent end 12 which may eithercontain the window 20 or the material of the barrier or sheath 10 may besubstantially optically transparent and present a closed end 12', bothcapable of extending over and covering the end of the medical or dentaltool or implement being inserted into an opening or canal of a patient.Further, with regard to the embodiment of the invention which containsthe optically transparent window 20, each barrier or sheath 10 can becompletely assembled by the manufacturer to provide a sterile sheath, orthe window 20 of the optically transparent material can be placed withinand adhered to the end 12 of the sleeve 14 and assembled on sight by adental or medical practitioner, or such practitioner's staff, whichenables the manufacturer to construct the tube or sleeve 14 out ofmaterial which is not necessarily optically transparent. Hence, thesheath or barrier 10 providing an optically transparent end forspecialized medical or dental tools or implements has been described inits various embodiments, and with explanations as to particular usage tomaintain the appropriate functioning and capabilities of the lightsensitive apparatus which it covers.

The present invention may be embodied in other specific forms withoutdeparting from the spirit or essential attributes thereof and,accordingly, the described embodiments are to be considered in allrespects as being illustrative and not restrictive, with the scope ofthe invention being indicated by the appended claims, rather than theforegoing detailed description, as indicating the scope of the inventionas well as all modifications which may fall within a range ofequivalency which are also intended to be embraced therein.

I claim:
 1. A disposable pathogen barrier for placement over and inproximate contact with a light emitting means of an intra-oral camerafor significantly reducing the spread of communicable and infectiousdiseases which may be transmitted by or through contact with human bodyfluids and tissues during a first and subsequent use of said intra-oralcamera in conjunction with the treatment of two or more patientseliminating the need for repeated sterilization of said intra-oralcamera between such uses for two or more patients comprising anelongated tubular sleeve terminating in a substantially circularaperture at a first end thereof and having an optically transmissivesecond end capable of freely passing emitted light rays from said lightemitting means for illuminating a designated area and receivingreflective light rays from said designated area without distortion,interruption or wavelength shifting, and for fitting over said lightemitting means of said intra-oral camera and preventing contamination ofthe outer surfaces of said light emitting means and said intra-oralcamera, said barrier having sufficient elastic material memory tomaintain itself in position covering said light emitting means and aportion of said intra-oral camera without slippage until manual removal.2. In accordance with claim 1, wherein said optically transmissivesecond end of said barrier overlies in juxtaposition and covers theillumination means of said light emitting means of said intra-oralcamera.
 3. In accordance with claim 1, wherein said opticallytransmissive second end of said barrier is further comprised of anoptically transparent film inserted into a substantially circular diecut in said sleeve proximal said second end and positioned along theinterior surface of said barrier by an adhesive bond around theperiphery of said die cut providing a seal for preventing contaminationof the surface of the light emitting means of said intra-oral camera. 4.In accordance with claim 3, wherein said optically transparent filmhaving a thickness in the range between 0.025 and 0.080 inches.
 5. Inaccordance with claim 1, wherein said barrier is made from anelastomeric or elastic material, natural or man-made, and combinationsthereof.
 6. In accordance with claim 1, wherein said barrier exhibitssufficient deformability, toughness and tear-resistance to stretch oversaid light emitting means and said portion of said intra-oral camera andto withstand pulling and stretching during application and removal.